Labia Majora Atrophy and Hypotrophy
Conditions
Brief summary
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler MMI-22-04-2019 on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.
Detailed description
MMI-22-04-2019 is a dermal filler recommended for application in the intimate area. It is a sterile, injectable, colorless transparent gel, non-pyrogenic, reabsorbable medical device. Its main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. The MMI-22-04-2019 is contained in pre-filled, graduated, disposable sterile syringe with Luer Lock adapter with 1 ml of net content. The sterilization of the product is achieved by moist heat. The MMI-22-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
Interventions
DEVICEMMI-22-04-2019
A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.
Sponsors
Mesoestetic Pharma Group S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female subject aged ≥18; * Subject presenting vulvar ptosis, deflation or aesthetic discomfort in the intimate area; * Subject who presents no type of pathology of the area to be treated; * Subjects who are willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation; * Clinically and anamnestically healthy individual; * Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid; * Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg; * Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min; * Respiratory rate between 12 - 24 breaths/min; * Axillar body temperature of up to 370С; * Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities; * Negative AIDS/HIV test; * Negative pregnancy test for the women with reproductive potential; * Reliable and acceptable method of contraception for the women of child-bearing potential * Signed written Informed Consent Form.
Exclusion criteria
* Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs; * Subject with history of vulvar cancer and/or previous regional radiotherapy; * Subjects with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites; * Subjects with history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection; * Subjects suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy; * Subjects uncontrolled systemic diseases; * Pregnancy, postpartum period (6 months) or post-lactation period (6 months); * Absence of a reliable and effective method of contraception; * Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment; * Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit inclusion in the study; * Subjects with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners; * Refusal to sign the Informed Consent Form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events [Safety and Tolerability] | From screening through study completion, an average of 90 days - daily. | Frequency and severity of adverse events (AEs) and adverse device effects. |
| Visual Analogous Scale (VAS) absolute change | From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks. | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogous Scale (VAS) | From Day 0 (Session 1) to Day 0 (immediately after application), 30 (up to 4 weeks) and 90 (up to 12 weeks) (Session 1, 2 and 4). | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. |
| Global Aesthetic Improvement Scale (GAIS) | From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). | The change in GAIS as evaluated by the PI based on the photographs of the treated area. A 5-point scale rating improvement in appearance compared to pre-treatment - 1 being exceptional improvement and 5 being worsened. |
| Subject satisfaction | Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). | Subject satisfaction based on Questionnaire, including visual analogue scale, ranged between 0 (least satisfied) and 10 (most satisfied) is used and questions about discomfort and satisfaction. |
Countries
Bulgaria
Outcome results
None listed